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Loperamide hydrochloride dimethicone compound rapidly disintegrating oral membrane

A technology of loperamide hydrochloride simethicone and loperamide hydrochloride, which can be applied in pharmaceutical formulas, active ingredients of artificially synthesized polymeric materials, and digestive system, and can solve slow disintegration, inconvenient carrying, and oral disintegration Problems such as complex preparation process of tablets and oral instant tablets

Inactive Publication Date: 2010-12-08
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are many oral preparations of loperamide hydrochloride and simethicone on the market at home and abroad, but because the traditional oral preparations must first disintegrate in the stomach to release the drug, the onset is slow and it is inconvenient to take. Although it can take effect quickly, it needs a spoon or a glass when taking it, and it is even more inconvenient to take it while driving, and it is not conducive to quantitative administration, and it is also inconvenient to carry. The preparation process of orally disintegrating tablets and orally dissolving tablets is more complicated , requires special equipment, slow disintegration when prepared by wet granulation and tableting technology, and unsatisfactory appearance, fragility and easy moisture absorption when prepared by freeze-drying method, which greatly affects the oral administration of loperamide hydrochloride and simethicone Application of preparation
Moreover, for the symptoms of diarrhea accompanied by flatulence in the gastrointestinal tract, no matter loperamide hydrochloride or oral preparations of simethicone are used alone, they cannot relieve the symptoms of both diarrhea and flatulence in the patient’s intestines well at the same time. Existing known technology also does not improve the suggestion of above defective

Method used

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  • Loperamide hydrochloride dimethicone compound rapidly disintegrating oral membrane
  • Loperamide hydrochloride dimethicone compound rapidly disintegrating oral membrane
  • Loperamide hydrochloride dimethicone compound rapidly disintegrating oral membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Determination of the dissolution time limit of loperamide hydrochloride simethicone compound oral instant film:

[0046] Take 10 sheets of medicine film randomly, one piece at a time, clamp one side of the medicine film with a clip with a jaw of about 2cm, and immerse the clip together in a water bath at 37°C, and use a stopwatch to time the medicine film from being immersed in water to dissolving And the time of breaking away from the clip is the melting time limit.

Embodiment 2

[0048] Loperamide Hydrochloride 1g

[0049] Simethicone 62.5g

[0050]Pullulan 50g

[0051] Maltodextrin 10g

[0052] Stevioside 2g

[0053] Polyethylene glycol-200 1g

[0054] Purified water 100g

[0055] Dissolve the above-mentioned amount of maltodextrin and stevioside in water to obtain an aqueous solution, then add the above-mentioned amount of amylopectin into the maltodextrin aqueous solution under stirring, fully stir and disperse to obtain a pullulan gel, and then add Polyethylene glycol-200 and stir evenly, finally add loperamide hydrochloride and simethicone and stir evenly to obtain loperamide hydrochloride simethicone gel, degas, uniformly add loperamide hydrochloride simethicone The gel is coated on a flat plate, heated and dried at 75-80° C., and cut to obtain the loperamide hydrochloride simethicone compound oral instant film. The film is white, flexible, melts and disperses quickly at the entrance, has a good taste and sweet taste, and the melting time i...

Embodiment 3

[0057] Loperamide Hydrochloride 1g

[0058] Simethicone Compound 62.5g

[0059] Hydroxypropyl methylcellulose (3 centipoise) 80g

[0060] Maltodextrin 40g

[0061] Sucralose 3g

[0062] Lemon essence 2g

[0063] Glycerin 1g

[0064] Ethylparaben 1g

[0065] Citric acid 2g

[0066] lemon yellow 2g

[0067] Purified water 150g

[0068] First dissolve the above-mentioned amount of maltodextrin, citric acid and sucralose in water to obtain an aqueous solution, then add the above-mentioned amount of hydroxypropyl methylcellulose (3 centipoise) into the aqueous solution under stirring, and stir thoroughly Disperse to obtain hydroxypropyl methylcellulose gel, take the above-mentioned amount of ethylparaben, heat and dissolve it with glycerin, then add it to the hydroxypropyl methylcellulose gel and stir evenly, and finally add loperamide hydrochloride , simethicone, lemon essence and tartrazine and stir evenly to obtain loperamide hydrochloride simethicone gel, degas, and ev...

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PUM

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Abstract

The present invention provides a hydrochloride loperamide dimethicone composite oral instant soluble membrane, which is used for relieving diarrhea with gastroenteric turgor symptom. The hydrochloride loperamide dimethicone composite oral instant soluble membrane contains hydrochloride loperamide and dimethicone; wherein, the weight proportion of the hydrochloride loperamide and the dimethicone is 1: 60 to 65 and the optimal weight proportion is 1:62.5. The present invention also discloses a preparation method of the hydrochloride loperamide dimethicone composite oral instant soluble membrane: water-soluble components are dissolved in water except for water-soluble polymers; at least a bio-acceptable water-soluble polymer ia added into a water solution under the stirring state; a polymer gel is obtained after full stirring and dispersing; a plasticizer is added into the polymer gel and evenly stirred; finally hydrochloride loperamide, dimethicone and other components are added to obtain the hydrochloride loperamide dimethicone polymer gel; degasifying is carried out, and the gel is evenly painted on a plate, blowing is carried out for heating and drying at the temperature of 70 to80 DEG, and cutting is carried out, thus the instant soluble membrane is obtained.

Description

technical field [0001] The invention relates to a loperamide hydrochloride simethicone compound oral instant film, which relates to a compound oral instant film preparation containing loperamide hydrochloride and simethicone and a preparation method thereof, which is used for relieving diarrhea accompanied by gastrointestinal flatulence symptoms. Background technique [0002] Loperamide Hydrochloride is an antidiarrheal drug that acts on opioid receptors on the intestinal wall to prevent the release of acetylcholine and prostaglandins, thereby inhibiting intestinal peristalsis and prolonging the residence time of intestinal contents. It can increase the tension of the anal sphincter, so it can inhibit fecal incontinence and urgency, and is used for acute and chronic diarrhea caused by various etiologies. For patients undergoing ileostomy, it can reduce the volume and frequency of defecation, and increase the consistency and hardness of stool. [0003] Due to the small surf...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61P1/14A61K9/70A61K31/451A61P1/12A61K31/80
Inventor 叶东陈庆财赵俊戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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